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Completed

NCT Number: NCT06642480

Distribution of CYP2D6 Multiplication, CYP2D6*5, and Clinical Implications in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia

Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. This study aimed to screen 63 postoperative patients (wild-type, CYP2D6*5, and CYP2D6 multiplication) of Minangkabau ethnicity in West Sumatera, Indonesia, who received tramadol using a modified long PCR method and to investigate the clinical impact of tramadol on the patients.

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rsup Dr M Djamil Padang

Padang, West Sumatra, 25129, Indonesia

About this study

VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post operative patients who get analgesic tramadol

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Post Operative Analgesia

Drug

administering 100 mg of intravenous tramadol 30 minutes before the operation is completed

Primary outcomes

  1. Determination of Patients' Visual Analogue Scale (VAS)

    Time frame: . It was observed in the recovery room at 30, 60, and 120 minutes

    Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Sponsors and collaborators

Lead sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Other Gov

Collaborators

  • Andalas University

Registry information

Official study title

Determination of Patients' Visual Analogue Scale (VAS) in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia

Acronym: Tramadol

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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